Evaluation of the Potential Effects of SSR149415 on the Hypothalamic-pituitary-adrenal Axis in Outpatients With Major Depressive Disorder (NAPA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01606384
First received: May 23, 2012
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

Primary Objective:

- To evaluate the effects of two fixed doses of SSR149415 (250 mg bid and 100 mg bid) on hypothalamic-pituitary-adrenal axis function in patients with major depressive disorder.

Secondary Objectives:

  • To evaluate the tolerability and safety of SSR149415 in patients with major depressive disorder.
  • To evaluate the efficacy of two fixed doses of SSR149415 compared to placebo in patients with major depressive disorder.
  • To evaluate plasma concentrations of SSR149415.

Condition Intervention Phase
Major Depressive Disorder
Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Study Evaluating the Pharmacodynamic Effects of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) on Hypothalamic-pituitary-adrenal Axis Function in Outpatients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Cortisol plasma concentration response to Corticotropin releasing factor (CRF) administration before and after 27 days of dosing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adrenocorticotropic hormone (ACTH) plasma concentration response to CRF administration before and after 27 days of dosing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
  • Changes in Hamilton Depression Rating Scale (HAM-D) depressed mood, factor and core items scores [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • Changes Clinical Global Impression (CGI) Severity and Improvement scores [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: December 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Twice daily
Drug: Placebo
Pharmaceutical form: Capsule Route of administration: Oral
Experimental: SSR149415 - 100mg
Twice daily
Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Pharmaceutical form: Capsule Route of administration: oral
Experimental: SSR149415 - 250mg
Twice daily
Drug: VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)
Pharmaceutical form: Capsule Route of administration: oral

Detailed Description:

The study consisted of three segments (A, B and C). Segment A was a 1 to 4-week, drug-free, screening and baseline period. Segment B was a 4-week, double-blind period. After the last dose of double-blind study medication in Segment B, all patients had to enter Segment C, a 1-week drug-free, follow-up period.

The total study duration for one patient participating in all segments of the study was 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) and the Mini International Neuropsychiatric Interview (MINI) criteria.

Exclusion criteria:

  • Outpatients unwilling to be hospitalized a total of 6 nights and 8 days.
  • Total score of less than 21 (<21) on the 17-item Hamilton Depression Rating Scale (HAM-D) at Visit 1 (Day -7) or Visit 5 (Day -1).
  • Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset or is secondary to a general medical disorder.
  • Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the MINI, except nicotine or caffeine dependence.
  • Patients who have used the following prior to entry into Segment B: any antipsychotic within 3 months; fluoxetine within 1 month; any monoamine oxidase inhibitor (MAOI) within 2 weeks; any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606384

Locations
United States, New Jersey
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01606384     History of Changes
Other Study ID Numbers: PDY5467
Study First Received: May 23, 2012
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014